Dry EyeNCT01741987
Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients
A study testing Optive ® and Fresh Tears ® in people with Dry Eye and Ametropia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Optive ® and Fresh Tears ®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
- DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:
- 2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.
- The patients, whose are going to be submitted for refractive surgery.
Who cannot join
- Any patient with punctual occlusion or punctual plugs.
- Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
- Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
- Patients with Epiphora.
- Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.
- Any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) and Post Refractive Surgery Patients
The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.
- Being tested
- Optive ®, Fresh Tears ®
- Medical subject headings
- Dry Eye Syndromes, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optive ®Other
instilation of 1 drop each eye 4 times per day
Fresh Tears ®Other
instilation of eye drop 4 times a day (qid)
| Study group | Role | What they receive |
|---|---|---|
| optive® eye drop | Active comparator | Not described Receives: Other: Fresh Tears ® |
| fresh tears ® eye drop | Placebo comparator | Not described Receives: Other: Optive ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients satisfaction with osmoprotective lubricant on different types DTS.
Measured: 3 months
Secondary outcomes (2)
Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.
Measured: 3 months
Physician satisfaction with Optive®
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossen Mihaylov Hazarbassanov, MD, PhD, Federal University of São Paulo
- Investigators
- Rossen M Hazarbassanov, MD, Principal investigator, Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741987
- Sponsor's protocol ID
- 1346/08
- Status last verified
- Feb 2017
- First submitted
- 27 Nov 2012
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) and Post Refractive Surgery Patients
- ClinicalTrials.gov ID
- NCT01741987
- Acronym / sponsor ID
- 1346/08
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optive® eye drop | Active comparator | Other: Fresh Tears ® |
| fresh tears ® eye drop | Placebo comparator | Other: Optive ® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
- DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:
- 2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.
- The patients, whose are going to be submitted for refractive surgery.
Key exclusion criteria (6 listed)
- Any patient with punctual occlusion or punctual plugs.
- Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
- Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
- Patients with Epiphora.
- Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optive ®instilation of 1 drop each eye 4 times per day | Other | fresh tears ® eye drop |
| Fresh Tears ®instilation of eye drop 4 times a day (qid) | Other | optive® eye drop |
Primary outcome
patients satisfaction with osmoprotective lubricant on different types DTS.
Time frame: 3 months
2 secondary outcomes
Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.
Time frame: 3 months
Physician satisfaction with Optive®
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- eye diseasesLink provided by the sponsor.
- FDA Resources on Drugs and DevicesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rossen M Hazarbassanov, MD principal investigator
Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optive ® and Fresh Tears ® in people with Dry Eye and Ametropia, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients satisfaction with osmoprotective lubricant on different types DTS. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.